Clinical Hold Decision
A clinical hold is the mechanism that CDER uses when it does not
believe, or cannot confirm, that the study can be conducted
without unreasonable risk to the subjects/patients. If this
occurs, the Center will contact the sponsor within the 30-day
initial review period to stop the clinical trial. CDER may either
delay the start of an early-phase trial on the basis of
information submitted in the IND, or stop an ongoing study based
on a review of newly submitted clinical protocols, safety
reports, protocol amendments, or other information. When a
clinical hold is issued, a sponsor must address the issue that is
the basis of the hold before the order is removed.
CDER's authority concerning clinical holds is outlined in Federal
regulations. The regulations specify the clinical hold criteria
that CDER applies to various phases of clinical testing. In
addition, all clinical holds are reviewed by upper management of
CDER to assure consistency and scientific quality in the Center's
clinical hold decisions.